Itch results in AD-15261

12-17 YEARS
Significant itch reduction
at Week 16 (secondary endpoint)1‑3,a,b

Adolescents ≥60 kg received DUPIXENT 300 mg Q2W after a 600 mg loading dose, and adolescents <60 kg received 200 mg Q2W after a 400 mg loading dose.1

Definitive conclusions cannot be made for time points earlier than Week 16 as those data were not multiplicity controlled and P value was nominal.

Itch data post hoc analysis4

12-17 YEARS
Itch reduction at Day 15 (mean change from baseline in Peak Pruritus NRS)
Limitations of analysis:
  • The prespecified itch endpoint in AD-1526 used weekly averaged Peak Pruritus NRS; this post hoc analysis is based on daily Peak Pruritus NRS4
  • Definitive conclusions cannot be made as this daily Peak Pruritus analysis (compared with weekly averaged analysis) was post hoc and was not statistically powered in this trial4

LSM, least squares mean.

aFull Analysis Set includes all subjects randomized.1

bIn the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders (59% and 21% in the placebo and DUPIXENT arms, respectively).1

cP<0.0001 vs placebo.4

Pruritus NRS assesses the average itch intensity over the previous 24 hours6

It is a patient-reported measure that uses a 0- to 10-point scale, with which patients are asked:

“On a scale of 0 to 10, how would you rate your itch overall (on average) during the previous 24 hours?”

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A reduction of at least 4 points in Peak Pruritus NRS from baseline is a clinically meaningful change.1